Active clinical trials for "Aortic Valve Disease"

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening (dilatation) of the aorta from its baseline size.

Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide. No larger prospectively randomized studies comparing the two methods have been reported. The aim of this study is to collect a large number of clinical data to create a proper basis for evaluation of the two techniques.

The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

A prospective, multicenter, nonrandomized, single-arm, clinical study.

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.